107th Congress

Report: Homeland Security: The Federal and Regional Response - Hearing Before the House Science Subcommittee on Environment, Technology, and Standards - June 10, 2002

Members Present

Representatives Constance A. Morella (R-MD), serving as Chairwoman; James A. Barcia (D-MI). Representative Roscoe Bartlett (R-MD), a member of the full Committee, also participated.

Witnesses

Panel One:

Elias A. Zerhouni, M.D., Director, National Institutes of Health (NIH); Arden Bement, Ph.D., Director, National Institute of Standards and Technology (NIST); Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID), NIH.

Panel Two:

Major Julie Pavlin, Chief, Department of Field Studies, Walter Reed Army Institute of Research; Edward McCallum, Director, Combating Terrorism Technology Support Office, U.S. Department of Defense; Robert A. Malson, President, DC Hospital Association, Chairman, Washington Metropolitan Council of Governments Bioterrorism Task Force.

NOTE: This report summarizes discussions relevant to Panel 1 only.

Purpose of Hearing: The hearing was called at the behest of Representative Morella to examine both Federal and regional responses to terrorism, and the pivotal role Maryland plays in that effort. With NIH, NIST, and other Federal agencies in Montgomery County, the subcommittee was interested in learning how these agencies work with private entities and entrepreneurs as each pursues activities to confront potential terrorist threats.

Opening Statements

Representative Morella opened by stating that she did not know about the President's plan to establish a Department of Homeland Security when the hearing was scheduled; however, she thinks such a department is a good idea. She noted the September 11 events, the anthrax releases, and the presence of NIH, NIST, and the Walter Reed Institute of Research in Montgomery Country with capabilities for responding. She said the subcommittee was interested in hearing about NIH reorganization efforts to respond to these events, promising NIST research efforts, and any legislative remedies the participants might suggest. She noted the importance of public-private partnerships and the value of technology transfer to the American people.

Statements of Witnesses

Panel One: Stating that biodefense research is at the top of NIH's research agenda, Dr. Zerhouni noted the longstanding role of Dr. Anthony Fauci and the NIAID in conducting and supporting relevant research. He noted the President's proposal for a U.S. Department of Homeland Security and said that the NIH will be working with the Administration on the development of the overall plan. Dr. Zerhouni highlighted the President's budget for FY 2003, which includes $1.7 billion for NIH to expand activities in basic research, comparative genomics, diagnostics, and vaccine and therapeutics development, and provide for construction of additional biosafety laboratories. Dr. Zerhouni then briefly described NIH research collaborations with the private sector. In particular, he cited recently announced anthrax genome research findings from The Institute for Genomic Research (TIGR), based in Montgomery County. This study was funded in part by NIAID and underscored how a new technology, whole-genome sequencing, and computational methods can analyze anthrax and other bacterial outbreaks, both planned and naturally-occuring releases. He said these techniques hold promise for more accurate tracing of the origin of individual bacterial strains. He said NIAID is building on this research by awarding additional funds to TIGR, in collaboration with Northern Arizona University, for expanded genomic analyses of additional anthrax strains and related bacteria.

Dr. Bement highlighted NIST activities and partnerships with its Federal and other partners. He said NIST has worked closely with the Federal Emergency Management Agency (FEMA), and with the U.S. Postal Service regarding the anthrax exposures. NIST also is expanding its efforts to coordinate with other Federal agencies. Dr. Bement noted that recently enacted laws have placed requirements on the agency related to biometrics and quantum computing. Biometrics will be used by the Government to screen immigrants. He said that NIST actively participates with its Montgomery County organizations and is a member of the local FEMA organization and the Chemical and Biochemical Task Force in Montgomery County.

Dr. Fauci discussed NIH activities and plans related to biodefense research and how they complement the U.S. Department of Defense (DoD) efforts to address biowarfare directed at military personnel. Describing the various organisms that could be used as potential bioterrorism agents, he said NIH has a long history of conducting and supporting research on these infectious organisms. Dr. Fauci discussed NIAID's biodefense strategic plan and research agenda, which he said are posted on the Institute's web site. He said both are founded on basic research and genomics, definable endpoints of therapeutics and vaccines, and diagnostics. He noted partnerships with other agencies, the center of which is the Office of Homeland Security (OHS). Dr. Fauci said that as part of the U.S. Department of Health and Human Services (DHHS), NIH will be interacting with many other Federal partners. He spoke of the anthrax release and other potential threats, and highlighted research activities, including dilution studies of the currently available smallpox vaccine, efforts to develop a new, second-generation anthrax vaccine, and phase I clinical trials of an ebola vaccine. Dr. Fauci spoke of the potential that a number of emerging and re-emerging organisms pose as threats, whether naturally occurring or intensional releases. He concluded that NIH will conduct biodefense research in the same way it does research on other infectious organisms, utilizing the very best fundamental basic research approaches.

Questions

Representative Morella

Dr. Fauci, you mentioned planned construction of additional biosafety level (BSL) 4 laboratories and the need for these. Currently, there is one dormant on the NIH campus. Are there any plans for its use?
Dr. Fauci said the current laboratory was built for research on multi-drug resistant tuberculosis. He noted that the proposed Building B on the NIH campus will provide additional BSL 3 laboratories for biodefense research. He said NIH will partner with DoD on a BSL 4 laboratory at Ft. Detrick, Maryland. He said NIH also will support extramural construction of regional centers of biodefense and emerging infections; these will have primary BSL 3 laboratories, but some BLS 4 as well.

There are concerns and disagreements regarding the development of vaccines against Class A agents and use of these vaccines in the general population. What can you tell us about this?
Dr. Fauci said we currently have vaccines for anthrax and smallpox. Research is ongoing to develop a more refined, recombinant anthrax vaccine. The current anthrax vaccine was not intended for general use, but for inoculation of individuals at high risk of exposure. A new smallpox vaccine for which work is ongoing will be very different from that given to children years ago. Dr. Fauci noted recent discussions on vaccine policy at a meeting at the National Academy of Sciences. He also said NIH at its Vaccine Research Center is doing fine work on an Ebola vaccine in monkeys.

Will you be called on for discussion regarding the proposed U.S. Department of Homeland Security?
Dr. Fauci indicated that NIH would ask to comment because NIH is best qualified to address biomedical research related to biodefense.

Regarding collaborations between NIH and NIST, is there anything that can be done to strengthen these and to utilize the resources of both agencies?
Dr. Bement said NIST and NIH have a longstanding relationship and that there are many issues for he and Dr. Zerhouni to discuss. Dr. Zerhouni said it is even more important now for the two agencies to work together. He said the two are synergistic in many ways.

Is there any specific information on how the NIH institutes and centers will be structured in the newly proposed Department?
Dr. Zerhouni said the new proposal is being viewed carefully. There are no firm plans for restructuring any particular institute or center. The fundamental fabric of NIH is its research, particularly that done by extramural researchers.

Were you part of the consultation in developing plans for the new Department?
Dr. Zerhouni said no, but that NIH certainly will be consulting in implementation discussions.

Are our technology transfer laws working well or do we need to do something in light of potential emergencies?
Dr. Zerhouni commented that Congress did a great job in passing legislation to ensure technology transfer. NIH has benefitted greatly from technology transfer returns. In the context of current patent laws, there could be some deleterious effects to technology transfer. He said he would like to work with Congress on these issues. He stated further that private industry should be encouraged to become involved in biodefense research and transfer of technology. Dr. Bement said NIST is involved primarily in activities related to the infrastructure of science and technology. The agency reports its results in open literature, but does not hold many patents. NIST's job is to fashion and transfer technology so that it might be used by first responders.

NIST has done an incredible amount of research since September 11, with particular emphasis on sensing technologies related to potential chemical, radiological, and nuclear attacks. There are many small companies with relevant products and ideas. Dr. Bement said NIST is working on new methods of highly precise mass spectrometry, microassay and DNA technology. The agency also is researching new x-ray standards to increase sensitivity for use at airports. He said NIST is very interested in products from industry that might prove useful and meet standards.

Representative Barcia

Can NIST assist in building and protecting infrastructure? Where do you see NIST in the new Department or would the agency be more useful as a resource?
Dr. Bement said NIST collaborates with all the Federal departments that might be placed in the new Department. The agency works with state and local governments, ports of authority, electricity and gas companies regarding infrastructure protections, and with the U.S. Department of Agriculture regarding food protection and irradiation.

Do you foresee any problems working with the new Department?
Dr. Barcia said NIST already has memoranda of understanding with Federal agencies related to emergency management, cybersecurity, and transportation safety. NIST can play a supportive role in the new Department's efforts.

Representative Bartlett

With your strategic plan and research agenda on the web, will this assist those who wish to harm us?
Dr. Fauci said we would like such persons to see our plans so that they know we are preparing for such events. NIH has always been transparent in the research that it conducts and supports to derive the maximum benefit through information sharing.

In the Dark Winter, a mathematical model was presented of what could happen with a smallpox release. Dr. Fauci noted the 77 million doses of smallpox vaccine resulting from the dilution studies, the purchase of additional quantities and the Adventus Pasteur donation as making it possible to vaccinate every United States citizen if it became necessary. He said the current idea is a Aring vaccination@ approach by which vaccinations would be given first to those exposed, then to contacts of those persons, then contacts of contacts and so on.

Do you have people out there who are generalists?
Dr. Zerhouni said NIH has generalists when it comes to basic research; however, this is not so with regard to clinical research. An important trend for NIH is to do systems research, to put all these pieces of information together. We are looking for bright young minds who can meet these new challenges.

Prepared by: Rosalind Gray/OD/OLPA, June 17, 2002